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  • Should we have risk management procedure including FMEA for all product lifecycle?

    We bought the toolkit MDR/ISO13485 and have the following question:

    If we are a manufacturer (specification holder) and we have contract manufacturer for all our products (so practically we outsource design and development and all manufacturing stages but we only do sales activities for products under our brand name/trademark), should we have a risk management procedure including an FMEA for all the product lifecycle? Or we only make a quality agreement with the manufacturer (OEM) which includes all the requirements and we supervise implementation?

    A note all our contract manufacturers are MDR Compliant and ISO 13485 Certified.

  • Supplier to a medical device company

    We supply components to medical device companies but actually do not make a medical device.  We are ISO 13485 because we choice to be not because we had to be.  Are we required to maintain a Medical Device File?

  • Is ISO 13485 for fertility company?

    I manage a Research and Development lab for a women’s fertility company. We develop kits and assays for genetic testing but we do not manufacture anything in our lab specifically. Would ISO 13485 be the right option for us?

  • Responsibilities of Distributors for collection of Medical Devices and incident reporting

    Responsibilities of Distributors for the collection of Medical Devices and incident reporting

  • Do medical device distributors and 3rd party logistics providers benefit from implementing ISO 13485 and MRD?

    We are a 3PL. I understand that the ISO 13485 regulations were designed specifically for Medical Device manufacturers. However, do medical device distributors and 3rd party logistics providers benefit from implementing these standards? Additionally, can 3PLs be certified under ISO 13485?

  • Implementation, Compliance software, Training

    Hello, we are a research lab and are looking at setting up a diagnostics lab to make 2 of our tests available (plus NHS are interested in using them).
    We need to get the lab ISO 15189 accredited but for the tests we perform, do we also need to be ISO13485 accredited?
    For one of the tests we supply a urine collection kit. If we are to send the kit to patients for sample collection do we need to be accredited (ISO13485)?
    The company we purchase the sample collection vessel from, are already ISO13485 accredited.
    We receive the sample from the patient and then perform analysis on it so is the extraction and instrument analysis kits regarded as medical devices?
    I'm a little confused so any help would be great

  • Change management

    we are being evaluated as a potential supplier. The customer provided us with an extensive questionnaire.

    An entire section is related to change management. From what I understand, the change management as such is not part of ISO 13485.

    I believe it is an FDA requirement.

    How should I answer the questions related to the change management without losing the trust of the customer?

    Or should I just create a new procedure?

  • Advanced notification of change

    What should be a typical timeframe for advance notification of change to our customers?

  • Medical component manufacturer and complaint handling


    I manage production and service for a medical component and device manufuacturer. Part of my role is complaints handling through our service department.

    I undestand the 13485 and FDA QSR requirements for complaints for our medical devices, but not our medical components. If a medical component is sent back to us from our OEM customer (who manufactures a medical device), does this constitute a complaint? For example - the OEM customer sends back a component we shipped them, which failed their incoming inspection. 

    Thank you! 

  • ISO 13485 for trading of medical devices

    Dears, I'm working currently in a company that export and import some medical devices (without manufacturing ), is it eligible to be certified with ISO 13485?

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